背景:患有乳腺癌的女性在癌症后面临许多重返工作(RTW)的障碍。FASTRACS-RCT的主要目的是评估FASTRACS(促进和维持乳腺癌后重返工作)干预对乳腺癌患者可持续RTW的影响,12个月后结束积极治疗。
方法:FASTRACS-RCT是一种前瞻性,国家,多中心,随机化,对照和开放标签研究。共有420例早期乳腺癌患者计划进行手术和(新)辅助化疗,将被随机分配(1:1的比例):(i)干预组,包括6个月内的四个步骤:移交干预工具;与全科医生(GP)进行过渡性医疗咨询;与公司的职业医师(OP)进行RTW前访问;与医院的RTW专家进行补诊(如果病假>10个月)(ii)控制组接受常规护理。FASTRACS干预措施的设计是通过干预图为健康促进计划中的复杂干预措施提供信息的,并涉及患者和相关利益相关者的代表。开发了特定的工具来弥合医院之间的差距,GP,OP和工作场所:乳腺癌患者的工具包,包括基于理论的指南;GP和OP的特定清单,分别为工作场所参与者提供基于理论的指南(雇主,经理,同事)。主要终点将关联可持续RTW(全职或兼职工作,工作时间为50%或更多,至少连续28天)和休息日。它将在积极的肿瘤治疗结束后的4、8和12个月进行评估。次要终点将包括生活质量,焦虑,抑郁症,RTW自我效能感,身体活动,社会支持,工作住宿,工作效率,工作状态,以及干预工具的有用性和可接受性。
结论:FASTRACS-RCT将辅以一种现实主义的评估方法,旨在了解环境对激活干预的机制和效果的影响。如果干预的预期影响得到确认,该干预措施将针对其他癌症和慢性病进行调整和扩大,以更好地整合医疗保健和工作残疾预防。
背景:NCT04846972;2021年4月15日。
BACKGROUND: Women with breast cancer face many barriers to return to work (RTW) after their cancer. The main objective of the FASTRACS-RCT is to evaluate the impact of the FASTRACS (Facilitate and Sustain Return to Work after Breast Cancer) intervention on the sustainable RTW of breast cancer patients, 12 months after the end of active treatment.
METHODS: FASTRACS-RCT is a prospective, national, multicentre, randomized, controlled and open-label study. A total of 420 patients with early breast cancer scheduled for surgery and (neo)adjuvant chemotherapy, will be randomly assigned (1:1 ratio) to: (i) the intervention arm comprising four steps over 6 months : Handing over the intervention tools; transitional medical consultation with the general practitioner (GP); pre-RTW visit with the company\'s occupational physician (OP); catch-up visit with a hospital-based RTW expert (if sick leave > 10 months) (ii) the control arm to receive usual care. The design of the FASTRACS intervention was informed by intervention mapping for complex interventions in health promotion planning, and involved patients and representatives of relevant stakeholders. Specific tools were developed to bridge the gap between the hospital, the GP, the OP and the workplace: a toolkit for breast cancer patients comprising a theory-based guide; specific checklists for the GP and the OP, respectively; and a theory-based guide for workplace actors (employer, manager, colleagues). The primary endpoint will associate sustainable RTW (full-time or part-time work at 50% or more of working time, for at least 28 consecutive days) and days off work. It will be assessed at 4, 8 and 12 months after the end of active oncological treatment. Secondary endpoints will include quality of life, anxiety, depression, RTW self-efficacy, physical activity, social support, job accommodations, work productivity, job status, and the usefulness and acceptability of the intervention\'s tools.
CONCLUSIONS: FASTRACS-RCT will be supplemented by a realist evaluation approach aimed at understanding the influence of context in activating the intervention\'s mechanisms and effects. If the expected impact of the intervention is confirmed, the intervention will be adapted and scaled-up for other cancers and chronic diseases to better integrate healthcare and work disability prevention.
BACKGROUND: NCT04846972 ; April 15, 2021.